Method And Apparatus For Laparoscopic aortic Repair By-Intravascular Devices

ABSTRACT

Medical methods and apparatus for locating and securing intravascular devices, substantially grafts or stents-grafts, via a laparoscopic duct created by a surgical procedure to approach a blood vessel lumen. A stapler including a tubular body having at its distal end a head with a die and die lid and at is proximal end a control mechanism with a retaining handle and a control lever pivotally thereto. The lever is operatively connected via a spring-loaded pressure rod with a fastener located in the die. The movement of lever is transformed into radial forces necessary for punching through the wall of the intravascular device and the surrounding blood vessel wall with a fastener and simultaneously bending ends of the fastener apart. Securing the ends of the intravascular device to the wall of a blood vessel is performed via a set of at least two staplers, each having several simultaneously deliverable fasteners.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to medical techniques, in particular, toapparatus and methods used to prevent an aorta rupture by means ofgrafts or stent-grafts. More particularly, the present invention relatesto methods and apparatus for securing intravascular devices, such asgrafts or stent-grafts, to the walls of blood vessels in direction fromthe inside of these vessels towards their outer surface.

2. Description of Related Art

An aortic aneurysm (or its rupture) is a most common form of arterialaneurysms. It is a very common type of deteriorating disease affectingthe ability of a lumen to conduct fluids and may be life threatening.The aortic aneurysm is a ballooning of the wall of an artery resultingfrom the weakening of the artery's wall due to disease or otherconditions. Left untreated, the aneurysm will frequently rupture,resulting in loss of blood through the rupture, the condition, whichoften leads to death.

The aorta is the main artery, which supplies blood to the circulatorysystem. The aorta arises from the left ventricle of the heart, passesupwards and bends over behind the heart, and passes down through thethorax and abdomen. Among other arterial vessels branching off the aortaalong its path, the abdominal aorta supplies two side vessels to thekidneys, the renal arteries. Below the level of the renal arteries, theabdominal aorta continues to about the level of the fourth lumbarvertabrae (or the navel), where it divides into the iliac arteries. Theiliac arteries, in turn, supply blood to the lower extremities andperineal region.

It is common for an aortic aneurysm to occur in that portion of theabdominal region between the renal arteries and the iliac arteries. Thisportion of the abdominal aorta is particularly susceptible to weakening,resulting in an aortic aneurysm. Such an aneurysm is often located nearthe iliac arteries. An aortic aneurysm larger than about five centimetrein diameter in this section of the aorta is ominous. Left untreated, theaneurysm may rupture, resulting in rapid, and usually fatal,hemorrhaging. Typically, a surgical procedure is not performed onaneurysms smaller than five centimetres because no statistical benefitexists in performing such procedures.

Aneurysms in the abdominal aorta are associated with a particularly highmortality rate; accordingly, current medical standards call for urgentoperative repair. Abdominal surgery, however, results in substantialstress to the body. Although the mortality rate for an aortic aneurysmis extremely high, there is also considerable mortality and morbidityassociated with open surgical intervention to repair an aortic aneurysm.This intervention involves penetrating the abdominal wall to thelocation of the aneurysm to reinforce or replace the diseased section ofthe aortic aneurysm. A prosthetic device, typically a synthetic tubegraft, is used for this purpose. The graft serves to exclude theaneurysm from the circulatory system, thus relieving pressure and stresson the weakened section of the aorta at the aneurysm.

Besides synthetic grafts, there are developed and widely used all overthe world particularly to prevent the rupture of aorta wallintravascular devices of the “stent-graft” type. They are inserted andlocated similarly to stents. The fixation of a stent-graft on the aortawalls is performed due to resilient forces of the material of thestent-graft itself usually having elastic members which bear up againstthe blood vessel wall or hook thereto. If the forces of resilient orelastic members of the stent-graft are insufficient for its fixation ina blood vessel, the stent-graft may be displaced from a given positionand moved along the aorta due to the blood flow and peristelsicoscillations of the walls of this blood vessel, which is very dangerousto the patient.

Repair of an aortic aneurysm by surgical means is a major operativeprocedure. Substantial morbidity accompanies the procedure, resulting ina protracted recovery period. Further, the procedure entails asubstantial risk of mortality. While surgical intervention may beindicated and the surgery carries attendant risk, certain patients maynot be able to tolerate the stress of intra-abdominal surgery. It is,therefore, desirable to reduce the mortality and morbidity associatedwith intra-abdominal surgical intervention.

In recent years, the common repair means is to deploy a stent-graftwithin the lumen of the affected aorta in the region of the aneurysm.These methods and devices have been developed to attempt to treat anaortic aneurysm without the attendant risks of intra-abdominal surgicalintervention. Among them are inventions disclosed and claimed in Parodi,Juan C. et al., WO 010487A1 for Graft Device for Treating AbdominalAortic Aneurysms and its patent family, including U.S. Pat. Nos.5,219,355, 5,522,880, 5,571,171, 5,643,208, 5,683,452, 5,693,087,6,102,942, EP 461791A1, EP 809980A3, EP 903118A2, EP 903119A3, EP903120A3 etc.

Parodi discloses a stent-graft device for locating inside an aortaaffected by an aneurysm causing the aorta to have an inner diametersmaller than the sum of inner diameters of the iliac arteries. The grafthas an upper main tubular portion dividing into two pending graft limbscapable of accommodating together within the restricted inner diameterof the aorta without the restriction of the aorta affecting the diameterof the limbs. The limbs have respective distal end portion withdiameters larger than the diameters of the graft limbs so as to beaccommodated and retained within the iliac arteries. Parodi'sstent-graft is inserted using a tubular device also disclosed in hispatent.

In other Parodi's patents there are disclosed stent-graft designs havinga metal wire frame collapsible to a minimal size sufficient to insertthe stent-graft into the artery through a puncture in its wall andexpandable inside the aorta to a required size under the action of aradial force, such as a balloon. This frame is covered by a sheath whichcan contract and expand together with the frame under the action ofexternal forces. Aforesaid stent-grafts are provided with means formechanical fixation to the walls of the aorta or iliac arteries. Amongthose means we find balloon cuffs of a special shape at the stent-graftends, see WO 010487A1, U.S. Pat. No. 5,522,880, U.S. Pat. No. 5,219,355,various hooks, elements shaped as scales, spirals and similar elementsdesigned for fixation on the wall of the aorta or artery, see U.S. Pat.No. 5,911,733 Endovascular Expander of a Non-migrant Positioning, EP948945A2 Endovascular Prosthesis with Fixation Means.

The problem of fixation of stents and stent-grafts inside the aorta andiliac arteries is PARTIALLY solved by other inventors likewise.

Lindenberg, Josef in EP 711135A1 discloses a stent with an improvedanchorage in a vessel. The stent can be expanded from a radiallycontracted insertion state into a radially expanded positioning statesuch that in the radially expanded state at least one end has a largerradial extension than the remaining main body of the stent.

Samuels in U.S. Pat. No. 5,423,851 discloses a method and apparatus foraffixing an endoluminal device to the walls of tubular structures withinthe body which utilizes incremental inflation of a balloon cuff todeploy radially projecting barbs attached to the cuff within a pluralityof recesses.

Kugler, Chad disclose in their patent WO 19943A1 a stent-graftcomprising radially expandable portions attached to one another andanchored to the aorta walls by a radial force. This stent-graft can bendto match the aorta longitudinal section by relative angular displacementof its portions.

Houser, Russel in WO 15144A1 discloses a system and components fortreating aortic aneurysms including a reinforcing graft and combinationsof fittings and rings for securing the graft to a host vessel, to branchvessels, for example, the iliac and renal arteries.

Edwin, Tarun et al., discloses in EP 868154A1 a structurally supportedgraft having a support structure with strain relief sections containingan internal surface, an external surface, or a wall thickness of atubular graft member. The structural support forms a spiral about thetubular graft.

Numerous suggestions of stent-graft inventors present various hooks andanchor members, integral or not integral with the stent-graft frame tofixate the latter inside the aorta or iliac arteries. Such suggestionsare disclosed in U.S. Pat. No. 6,015,431, EP 747020A2, EP 701800A1, EP657147 A2, EP 466518A2, U.S. Pat. No. 5,669,936, U.S. Pat. No.6,004,347, U.S. Pat. No. 5,733,325, U.S. Pat. No. 5,104,399, U.S. Pat.No. 6,030,413.

All the above-mentioned inventions have, in our opinion, a commondrawback, which consists in the fact that the stent-grafts fixation onthe inner walls of the aorta and iliac arteries is not reliable enoughand brings to many complications. Therefore, under the action of bloodflow and peristaltic oscillations of artery walls, stent-grafts aredisplaced from their proper positions, which may have grave consequencesfor the patient and result in his death because of the aorta rupture.

3. The Prior Art

Closest to the present invention are inventions disclosed and claimed inTaheri, Syde, U.S. Pat. No. 5,843,169 for Apparatus and Method forStapling Graft Material to a Blood Vessel Wall while Preserving thePatency of Orifices and inventions disclosed and claimed by Tanner,Howard, in U.S. Pat. No. 5,944,750 for Method and Apparatus for theSurgical Repair of Aneurysms, U.S. Pat. No. 5,957,940 for Fasteners forUse in the Surgical Repair of Aneurysms and U.S. Pat. No. 5,997,556 forSurgical Fastener.

Taheri, Syde in U.S. Pat. No. 5,843,169 discloses an apparatus forstapling graft material to a blood vessel wall comprising a staplingdevice, a balloon catheter, a sheath, and an inflation means.

The apparatus design suggested by Tahery is, in our opinion, inoperativeas the radial force generated by a balloon is inadequate to insert asecuring member shaped as a nail into the wall of the aorta or artery.It is especially unlikely if the wall of the aorta or artery is coveredwith calcium plaques.

Tanner, Howard in U.S. Pat. No. 5,944,750 discloses an attachmentassembly and repair graft for securing to repair a vessel having ananeurysm therein. The attachment assembly comprises an attachment cuffsuch that the graft is not dimensionally dependent upon the size of thevessel. The apparatus also comprises a visualization apparatus for realtime direct viewing of an interior of a vessel. A penetration apparatusis disclosed for use in forming treatment specific holes in apotentially calcified vessel wall, which facilitates thereafter thesecuring of the graft and attachment assembly to the vessel wall. Anintroducer sheath device is also disclosed that comprises a sealingassembly for preventing the loss of blood from the vessel during theinsertion and subsequent removal of surgical components during thesurgical procedure.

In U.S. Pat. No. 5,957,940 and U.S. Pat. No. 5,997,556, H. Tanner alsodiscloses fasteners for use during a surgical procedure for securingsurgical components to a blood vessel wall under a compressive force.According to the inventions, the fastener assemblies are shaped ascoiled springs or spirals or a plurality of entwined coil springs orring type fasteners including a plurality of rings.

All the described inventions by Howard Tanner have, in our opinion, acomplicated and not adequately reliable design and limited functionalpossibilities. So, in particular, the apparatus for setting the securingelements cannot be brought in operative position inside iliac arterieshaving a small lateral diameter. Because of limited space it isimpossible to bend the end of the apparatus working head for setting thesecuring elements in the stent-graft wall. The efficiency of thisapparatus for drilling holes in the walls of the stent-graft, aorta andiliac arteries is doubted, especially if these walls are calcified andcovered by calcium plaques. In general, we think that the apparatuspresented by Howard Tanner can be used only inside the aorta and notinside iliac arteries. As far as the suggested securing elements areconcerned, we believe that their fixation in the inner walls of theaorta and iliac arteries is not reliable enough. Therefore, under theaction of blood flow and peristaltic oscillations of artery walls, thestent-graft may be displaced from its proper position, which may havegrave consequences for the patient and may result in his death due tothe aorta rupture.

And finally, there are are known devices developed in France by ThierryRichard, Eric Perouse, such as “Surgical staple inserter”, see U.S. Pat.No. 5,346,115; WO 9217117; EP 0533897 and “Surgical staple for tissue”,see Pat. FR 2746292.

U.S. Pat. No. 5,346,115; WO 9217117; EP 0533897 describes a surgicalstaple inserter for joining two ducts such as a blood vessel and bloodprosthesis. The staple inserter ejects staples in a radial directionrelative to the axis of the ducts. In one embodiment, it includes astaple holder surrounded by the prosthesis and containing a series ofstaples arranged in at least one ring. All the staples are ejectedsimultaneously. The staple inserter also includes an anvil outside theorganic duct, and a device for spacing apart the anvil and the stapleholder in relation to their relative working position. Projections holdthe prosthesis in place during the insertion of the staple holder intothe ducts.

One of the drawbacks of this device is the complexity of its design, butits chief drawback is that it does not allow to bend the ends of stapleswhen they are extending from the device body outwardly, through theprosthesis and the blood vessel wall. Therefore it is necessary toprovide the device with anvils arranged outside the operated bloodvessel, and this makes both the device itself and the whole operationfor setting a stent-graft more complicated and expensive.

Pat. FR 2746292 describes a surgical staple having a circular spiralformed of metallic wire. It extends on a complete spiral, which isaugmented over part of its length. The staple can have a barbed end. Thedevice for this staples insertion comprises a guide tube, extendingtowards the front by an inwardly curved section with a guide channel. Atleast a section of metal wire moves in the guide tube. A pusher movesthe wire section towards the distal end of the guide tube.

The device has several drawbacks. It is rather difficult to set thestaples as the device must be positioned very accurately relative to theprosthesis wall, it is impossible to set several staples simultaneously,and considerable projection of parts of staples inside the prosthesismay result in an accelerated thrombogenesis in this prosthesis lumen.

On the whole, today no methods and apparatus for grafts and stent-graftsfixation to the walls of a blood vessel from inside this vessel, thatare developed, brought to mass production and use in real practice, areknown to the authors of the present invention.

An object of the present invention is to provide reliable and relativelysimple means for securing a graft, stent-graft or other intravasculardevices to the wall of the aorta, iliac arteries or other arteries, inparticular, a new and improved method for stapling and a staplingapparatus based on this method.

Another object of the present invention is to provide suturing of aprosthesis to a blood vessel over the whole perimeter of connection, aswell as security and tightness of this connection even in such hard toreach spots, as the aorta neck or in the area immediately under renalarteries.

SUMMARY OF THE INVENTION

The present invention includes a method for intraluminal fixation ofintravascular devices, such as grafts or stent-grafts.

The method includes several successive steps. At the first step aspecial stapler is prepared for the operation. For this purpose there ischecked the state of its loading with fastener means (loaded orunloaded) and, if necessary, it is being loaded. Then a correspondingintravascular device, substantially graft or stent-graft, is fitted overthis stapler body, with partial reversing, if necessary, of one end ofthis intravascular device. Thereupon the fitted intravascular device issecured on the stapler body via a means for its temporary fixation. Atthe next stage there is created, by a surgical procedure, a duct forapproaching the lumen of an operated blood vessel, substantially theaorta, directly through the wall of this blood vessel. Then, through theduct thus opened there is inserted into the lumen of the operated bloodvessel, substantially the aorta, a special stapler with a correspondingintravascular device, substantially graft or stent-graft, fitted overand secured thereon, and this intravascular device is located in arequired position. Thereafter the stapler is brought into operativeposition necessary for securing the first end of the intravasculardevice, in this case a graft, to the wall of a blood vessel,substantially the aorta. Then the matching of mutual location of thefirst end of this intravascular device, the place of its supposedsecuring to the blood vessel wall, as well as the stapler actuator withfastener means located near its free end.

Then in the stapler actuator there are generated radial forcessufficient to act on fastener means. Due to this force fastener meansextend from the actuator radially, punch the wall of the intravasculardevice in such a way that the distal ends of these fastener means arepartly outside the blood vessel and are bent over on its outer surfaceto form a rigid connection of the first end of this intravascular devicewith the blood vessel wall. Then the stapler actuator is moved clear ofthe first end of the wall of this intravascular device, so that thefastener means remain fixed in the wall of this intravascular device andin the blood vessel wall to secure the first end of this intravasculardevice with a corresponding blood vessel portion and prevent thereby anyits displacement relative to this blood vessel. Next the stapler isbrought into inoperative position necessary for its free removal andremoved from the intravascular device and from the blood vessel.

At the next step in the intravascular device (graft or stent-graft)there is made an incision to approach its lumen. Then another specialstapler for securing the second end of the intravascular device to thewall of a given blood vessel (aorta) is inserted via a previously madeduct and via the incision into the lumen of this intravascular device(graft or stent-graft). This stapler is brought into operative positionwhereupon its actuator with fastener means located in the die at itsfree end is brought to the wall of the intravascular device, at the spotof its second end connection with the blood vessel wall. Then there ischecked the matching of positioning of the second end of thisintravascular device, the place of its supposed securing to the bloodvessel wall, as well as of the stapler actuator with fastener means. Atgenerating in this stapler actuator an axial force sufficient to act onfastener means these fastener means extend from the actuator in radialdirection, punch the wall of this intravascular device and surroundingblood vessel wall in such a way that the distal ends of these fastenermeans partly come outside the blood vessel and are bent over on itsouter surface to form a rigid connection of the second end of thisintravascular device with the blood vessel wall. Then the actuator ofthe other stapler is moved clear of the wall of this intravasculardevice, whereby fastener means remain fixed in the wall of thisintravascular device and in the blood vessel wall to secure the secondend of this intravascular device with a corresponding portion of theblood vessel and prevent thereby any its displacement relative to thisblood vessel. Then the stapler is brought into inoperative positionnecessary for its free removal from the intravascular device and removedtherefrom and from the blood vessel.

At the last step, by a surgical procedure, there are closed the incisionin this intravascular device and the duct to approach the lumen of theintravascular device and the blood vessel lumen.

Owing to the above manipulations there is created a secure multiple-spotconnection of the intravascular device with the blood vessel wall whichprevents the displacement of this intravascular device from an assignedposition due to blood flow and peristelsic oscillations of the bloodvessel wall.

According to the claimed method, it is possible to secure anintravascular device, such as graft or stent-graft, to a blood vesselwall via at least one suggested stapler and using at least two fastenermeans simultaneously more than at two points. This is performedsubstantially near one of the free ends of this intravascular device.

According to the suggested method, it is also possible to secure theends of an intravascular device, such as a stent-graft, having a broadproximal part and bifurcated distal part to the wall of a blood vessel(the aorta), via a set of at least two staplers and using in each ofthem simultaneously at least two fastener means. The set contains atleast one first stapler for securing the broad proximal part of astent-graft with the aorta wall and at least one second stapler forsecuring the bifurcated part of this stent-graft to the aorta wall. Theproximal end of a stent-graft having a broad proximal part is secured tothe wall of a blood vessel (aorta) in the aorta neck area via the firstof staplers comprised in the stapler set and using simultaneously atleast two said fastener means.

The distal end of a stent-graft having a bifurcated distal part issecured to the aorta wall via the second of staplers comprised in theset and using simultaneously at least two fastener means. This isperformed near the free end of the first or second branches of thebifurcated distal part of this stent-graft.

At last, according to the claimed method, the stent-graft may be securedto the aorta wall using at least two fastener means near the free end ofboth branches of the bifurcated distal part of this stent-graft.

The claimed invention also includes a stapler for laparoscopic aorticrepair by intraluminal fixation of intravascular devices, substantiallygrafts or stent-grafts. This stapler comprises: a tubular body, a headwith a die and die lid disposed at one end of the tubular body, as wellas a control mechanism mounted at the opposite end of this tubular body,a pressure rod located within the latter and, at last, means fortransmitting axial force from the pressure rod to fastener means and fortemporary fixation of delivered intravascular devices on the staplerbody.

The stapler tubular body is adapted for positioning within a bloodvessel and is rigid in longitudinal direction and flexible in lateraldirection.

The stapler head, substantially of cylindrical shape, is disposed at thefree end of the tubular body and has an inner axial cavity proximal endand distal end. At the proximal end of this head there are rigidlysecured a die and die lid aligned with this head and with one another.

The die serves for locating fastener means, substantially U-shapedstaples. It is shaped substantially as a barrel having a proximal end,distal end, substantially cylindrical generatrix and an inner axialcavity which is open on the side of barrel distal end and terminates ina bottom at the proximal end of this barrel. This bottom has a throughaxial hole, through, evenly arranged radial slots, and on its end facepresented to the die lid—recesses with grooves for locating fastenermeans, substantially U-shaped staples. These recesses with grooves arecoaxial with radial slots and provided with means for setting apart theends of U-shaped staples which are disposed along the groove axes,immediately adjacent to the die generatrix and are substantiallyV-shaped.

The die lid has a substantially cylindrical generatrix, proximal anddistal end faces, radial slots evenly arranged in the body of this dielid near its distal end face and extending onto its cylindricalgeneratrix, as well as means for retaining the free ends of U-shapedstaples and means for separating from the stapler the middles of theseU-shaped staples at the end of their working stroke. All these means aredisposed near the points of intersection of radial slots with the distalend face and cylindrical generatrix of this die lid.

The control mechanism is disposed at the tubular body end opposite tothe head and includes a substantially cylindrical hollow body with aproximal end and a distal end with a retaining handle extending from thebody at a certain angle, from about 30 degrees to about 90 degrees and acontrol lever pivotally mounted on this retaining handle.

The pressure rod is located within the hollow body. It has alongitudinal axis, a proximal end and a distal end. This pressure rod isrigid in longitudinal direction and flexible in lateral direction and isoperatively associated via its distal end with the control lever, andits proximal end is substantially conical and is disposed in the inneraxial cavity of the die to reciprocate relative to the latter.

Means for transmitting axial force from the pressure rod to fastenermeans, substantially U-shaped staples, and for converting this axialforce into radial forces applied to each of these U-shaped staples, aredisposed substantially in the inner axial cavity of the die toperiodically cooperate with the proximal end of the pressure rod.

The stapler also has a means for temporary fixation on its body ofintravascular devices, substantially grafts or stent-grafts located onthis stapler body outside.

The stapler control mechanism has a substantially cylindrical hollowbody with a proximal end, a distal end and retaining handle extendingsidewise therefrom at a certain angle, from about 30 degrees to about 90degrees, the handle being provided with a swing lock and control leverpivotally attached to this handle. The control lever has a pressure endmovably secured within the hollow body in the clearance between thespring-loaded end of the pressure rod and an adjusting screw alignedwith this pressure rod.

The die for receiving fastener means is shaped as a barrel with asubstantially cylindrical generatrix and an inner axial cavity open onthe side of the barrel distal end and terminating in a bottom at theproximal end of this barrel. The die has through, evenly arranged radialslots on its bottom, and on the end face of this bottom facing the dielid—recesses with grooves for receiving fastener means, substantiallyU-shaped staples, with means for setting apart the ends of the latter.These recesses with grooves have substantially equal depth relative tothe end face of die bottom and are aligned with the radial slots. Theymay also have different depth relative to the end face of die bottom,but even in this case they are also aligned with the radial slots. Therecesses with grooves may have at least two different depths relative tothe end face of die bottom, recesses with grooves of different depthsalternate with one another.

The fastener means are shaped substantially as U-shaped staples anddisposed radially in the grooves of stapler die to extend radially fromthese grooves due to radial forces. The free ends of U-shaped staplesare located on both sides of means for setting apart the ends of thesefastener means disposed along the axes of grooves, immediately adjacentto the die cylindrical generatrix and are substantially V-shaped.

Means for setting apart the ends of fastener means, substantiallyU-shaped staples, are disposed along the axes of grooves, immediatelyadjacent to the cylindrical generatrix of the die and are substantiallyV-shaped, with lateral faces which are substantially curvilinear orradial, concave and diverging from one another in direction from thecenter of this die to its cylindrical generatrix, which allows to bendoutwardly the free ends of fastener means during their extension fromthe die due to said radial forces.

The die lid is provided with means for retaining the free ends offastener means, substantially U-shaped staples, containing springymembers disposed in the lid near the intersection points of radial slotswith the distal end face and cylindrical generatrix of this die lid.

The die lid is further provided with means for separating from thestapler the middles of fastener means, substantially U-shaped staples,at the end of their working stroke. These means contain recesses locatednear intersection points of radial slots with the distal end face andcylindrical generatrix of this die lid. Besides, the die lid is made ofa transparent material to check the state of fastener means,substantially U-shaped staples.

The pressure rod has a longitudinal axis, a substantially conicalproximal end, a distal end and a thrust collar near its distal end. Thispressure rod is rigid in longitudinal direction and flexible in lateraldirection. The pressure rod is spring-loaded, operatively associated viaits distal end with the control lever and disposed so as to reciprocate,by its distal end—within the hollow body of said control mechanism, andby its substantially conical proximal end—within the inner axial cavityof the die. The pressure die has a substantially conical proximal endwith a cone vertex angle from about 3 degrees to about 35 degrees. Thevalue of this angle is substantially defined from about 10 degrees toabout 20 degrees.

The means for transmitting axial force from the pressure rod to fastenermeans, substantially U-shaped staples, and for converting this axialforce into radial forces applied to each of these U-shaped staplescontains curved L-shaped levers pivotally secured via the end of itslong arm and evenly arranged in the inner axial cavity of the die insuch a way that their short arms bent outwardly relative to the dielongitudinal axis are located in corresponding through radial slots onthis die bottom, the bent L-shaped levers capable of periodicalcooperation by inner faces of their long arms with the substantiallyconical proximal end of the pressure rod, and by their free ends ofoutwardly bent short arms—with the middles of corresponding U-shapedstaples. Curved L-shaped levers are pivotally mounted via the ends oftheir long arms on a ring located within the inner axial cavity of thedie, in the clearance between the head free end and inner ribs of thisdie extending from the wall of its inner axial cavity towards the dielongitudinal axis. The ribs have evenly arranged radial slots each ofthem receiving a corresponding movable curved L-shaped lever.

The die, die lid and fastener means, substantially U-shaped staples,located in die grooves form in combination a single set of the stapleractuator which is configured to be removed from the stapler body withfollowing replacement by other, similar interchangeable sets.

The means for temporary fixation on the stapler body of deliveredintravascular devices, substantially grafts or stent-grafts, located onthis stapler body outside substantially contains an adjusting screw witha thrust head located in the distal part of control mechanism body,coaxially with the pressure rod and on the other side of the pressureend of control lever, as well as fastener means, substantially U-shapedstaples, with which this adjusting screw is operatively connected viathe pressure end of control lever and pressure rod.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in conjunction with the followingdrawings in which like reference numerals designate like elements andwherein:

FIG. 1 shows a longitudinal section of the stapler according to thefirst embodiment of the present invention;

FIG. 2 shows a longitudinal section of the stapler head and dieaccording to the first embodiment of the present invention;

FIG. 3-5 show the first embodiment of the stapler die—its longitudinalsection, front view and a groove close-up;

FIG. 6 shows a longitudinal section of the stapler according to thesecond embodiment of the present invention;

FIG. 7 shows a longitudinal section of stapler head and die according tothe second embodiment of the present invention;

FIG. 8-10 show the second embodiment of the stapler die—its longitudinalsection, front view and a groove close-up;

FIG. 11 shows an L-shaped lever and diagram of its cooperation with thepressure rod;

FIG. 12 shows a diagram of L-shaped levers securing on a ring;

FIG. 13-14 show diagrams of locating a graft or stent-graft using a setof claimed staplers.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following descriptions of the preferred embodiments of the presentinvention are described. The inventors of the present subject mattercontemplate that the embodiments described herein are capable of use inthe repair of other vessels and in other procedures. Thus, it isintended that the present invention cover the modifications andvariations of the invention, provided they come within the scope of theappended claims and their equivalents.

The most preferable embodiments of the stapler according to the presentinvention are shown in drawing FIG. 1-10.

The claimed invention (FIG. 1) includes stapler 1 for laparoscopicaortic repair by intraluminal fixation of intravascular devices,substantially grafts or stent-grafts 3.

Stapler 1 comprises (FIG. 1): a tubular body 10, head 12 with die 14 anddie lid 16 located at one end of tubular body 10, as well as controlmechanism 18 mounted at the opposite end of tubular body 10. Tubularbody 10 of stapler 1 is adapted to be positioned within a blood vesseland is rigid in longitudinal direction and flexible in lateraldirection. Tubular body 10 encloses pressure rod 20.

Substantially cylindrical head 12 of stapler 1 is disposed at the freeend of tubular body 10 (FIGS. 1, 2) and has an inner axial cavity 22,proximal end 24 and distal end 26 (FIG. 2). At the proximal end 24 ofhead 12 there are rigidly secured die 14 and die lid 16 coaxial withthis head 12 and with one another.

Die 14 serves for receiving fastener means, substantially U-shapedstaples 28 (FIG. 2). Die 14 is shaped substantially as a barrel having aproximal end 30, distal end 32, substantially cylindrical generatrix 34and inner axial cavity 36 open on the side of the distal end 32 of thebarrel and terminating in bottom 38 (FIGS. 2, 3) at the proximal end 30of the barrel. This bottom 38 has a through axial hole 40 (FIGS. 3, 4,5), through, evenly arranged radial slots 42, and on its end face 44presented to die lid 16—recesses with grooves 46 for receiving fastenermeans, substantially U-shaped staples 28. These recesses with grooves 46are coaxial with radial slots 42 and provided with means for settingapart the ends of U-shaped staples—bulges 48 which are disposed alongthe axes of grooves 46, immediately adjacent to generatrix 34 of die 14and substantially V-shaped (FIG. 5). Bulges 48 are substantiallyV-shaped, with lateral guiding faces 50 which are substantiallycurvilinear or radial, concave and diverging from one another indirection from the center of said die 14 to its cylindrical generatrix34.

Recesses with grooves 46 have substantially the same depth relative toend face 44 of the bottom of die 14 and are coaxial with radial slots42. They may also have a different depth relative to end face 44 of thebottom of die 14, but they are also coaxial with radial slots 42. Inanother embodiment of die 14 recesses with grooves 46 have at least twodifferent depths relative to end face 44 of the bottom of die 14,recesses with grooves 46 of different depths are arranged alternatelywith one another.

Fastener means, substantially U-shaped staples 28, are disposed radiallyin grooves 46 of die 14 of stapler 1 to extend radially from thesegrooves 46 due to radial forces. The free ends of U-shaped staples 28are located on both sides of means for setting apart these fastenermeans—bulges 48 disposed along the axes of grooves 46, immediatelyadjacent to cylindrical generatrix 34 of die 14 and substantiallyV-shaped.

Lid 16 of die 14 has a cylindrical generatrix 52, proximal 54 and distal56 end faces, as well as radial slots evenly arranged in the body of lid16 near its distal end face 56 and extending onto its cylindricalgeneratrix 52. Besides, lid 16 is provided with means for retaining thefree ends of U-shaped staples 28 and means for separating from thestapler the middles of these U-shaped staples 28 at the end of theirworking stroke. All these means are located near the points ofintersection of radial slots 42 with distal end face 56 and cylindricalgeneratrix 52 of this lid 16. Means for retaining the free ends offastener means, substantially U-shaped staples 28, contain cantileverspringy members 58 (FIG. 2) created in the body of lid 16 by cuttingtherein weakening slots 42 and located near the points of intersectionof radial slots 42 with distal end face 56 and cylindrical generatrix 52of this lid 16.

Lid 16 is also provided with means for separating from stapler 1 themiddles of fastener means, substantially U-shaped staples 28 at the endof their working stroke. These means are shaped as recesses 60 locatednear the points of intersection of radial slots 42 with distal end face56 and cylindrical generatrix 52 of this lid 16 (FIG. 2). Besides, lid16 is made of a transparent material for checking the state of fastenermeans, substantially U-shaped staples 28.

Die 14, lid 16 and fastener means, substantially U-shaped staples 28located in grooves 46 of die 14 form in combination a single set of theactuator of stapler 1 which is configured to be removed from stapler 1and replaced by other, similar interchangeable sets (FIG. 2).

Control mechanism (FIG. 1) 18 is located at the opposite to head 12 endof tubular body 10 and includes a substantially cylindrical hollow body62 with proximal end 64 and distal end 66 with a retaining handle 68provided with a swing lock 70 and control lever 72 pivotally mounted onthis handle. This handle extends from distal end 66 sidewise at acertain angle, from about 30 degrees to about 90 degrees. Control lever72 has a pressure end 74 movably mounted within hollow body 62 in theclearance between spring-loaded end of pressure rod 20 and adjustingscrew 76 coaxial with this pressure rod 20.

Pressure rod 20 (FIG. 1) is located within hollow body 10. It has alongitudinal axis 78, proximal end 80, distal end 82 and thrust collar84 near its distal end 82. This pressure rod 20 is rigid in longitudinaldirection and flexible in lateral direction. Pressure rod 20 is loadedwith a spring 86, operatively associated via its distal end 82 withcontrol handle 72 and capable of reciprocating, by its distal end82—within hollow body 62 of control mechanism 18, and by itssubstantially conical proximal end 80—in inner axial cavity 36 of die14. Pressure rod 20 has a substantially conical proximal end 80 (or tip88, as shown in the first embodiment of the stapler) with a cone vertexangle from about 3 degrees to about 35 degrees. The value of this angleis defined from about 10 degrees to about 20 degrees.

Means for transmitting axial force from pressure rod 20 to fastenermeans, substantially U-shaped staples 28, and for converting this axialforce into radial forces applied to each of these U-shaped staples 28are located substantially in inner axial cavity 36 of die 14 forperiodical cooperation with the proximal end of pressure rod 20. Meansfor transmitting axial force contain curved L-shaped levers 90 (FIGS. 2,11, 12) pivotally mounted by the end of their long arms 92 in the inneraxial cavity of die 14 in such a way that their short arms 94 bentoutwardly relative to the longitudinal axis of the die are disposed incorresponding through radial slots 42 on bottom 38 of this die 14, andcurved L-shaped levers 90 are configured to periodically cooperate viainner faces 96 of their long arms 92 with a substantially conicalproximal end of pressure rod 80 (or tip 88), and via their free ends 98of outwardly bent short arms 94—with the middles of correspondingU-shaped staples 28. Curved L-shaped levers 90 are pivotally mounted viathe ends of their long arms 92 on ring 100 (FIGS. 2, 11, 12) located ininner axial cavity 36 of die 14, in the clearance between the free endof head 12 and inner ribs 102 of this die 14 extending from the wall ofits inner axial cavity 36 towards the longitudinal axis of die 14. Ribs102 have evenly arranged radial slots 104 (FIG. 3) each of themreceiving a movable corresponding curved L-shaped lever 90.

Stapler 1 also has a means for temporarily fixating on its body thedelivered intravascular devices, substantially grafts or stent-grafts 3,located on this body of stapler 1 outside. This means is substantiallyan adjusting screw 76 (FIG. 1) with a thrust head disposed in distalpart 66 of body 62 of control mechanism 18, coaxially with rod 20 and onthe other side of pressure end 74 of control lever 72, as well asU-shaped staples 28 wherewith this adjusting screw 76 is operativelyassociated via pressure end 74 of control lever 72 and pressure rod 20.

All staplers 1 set forth hereinabove relate to its first embodiment,that is to a stapler serving substantially for delivering a graft orstent-graft and its fixation in the aorta neck. The second embodiment ofthe stapler has exactly the same design and differs from the firstembodiment solely in a smaller diameter of head 12, die 14 and lid 16,as well as in a smaller number of U-shaped staples 28 located therein,as it is intended for fixation of graft or stent-graft 3 in bifurcationswith a smaller lumen. Besides, in the second embodiment of stapler 1there is slightly changed the form of curved L-shaped levers 90, butthey perform their functions exactly in the same way as correspondinglevers 90 in the first embodiment of stapler 1. Therefore all, designelements of the second embodiment of the stapler shown in FIG. 6-10 havethe same reference numerals as corresponding design elements accordingto the first embodiment shown in FIG. 1-5.

Besides stapler 1, the present invention includes a method for securingan intravascular device, such as graft or stent-graft 3, to the wall ofa blood vessel, substantially aorta 200 (FIGS. 13, 14).

Let us consider, by way of example, the claimed method for securing anintravascular device using claimed stapler 1 for securing graft 3. Themethod includes several successive steps (FIG. 13). At the first stepspecial stapler 1 is prepared for the surgical procedure. To this endthere is checked the state of its loading with fastener means—U-shapedstaples 28 (loaded or unloaded), and, if necessary, it is loaded. Thenthere is fitted over head 12 with die 14 and body 10 of this stapler 1 acorresponding intravascular device, substantially graft or stent-graft3, with partial reversing, if necessary, of one end of thisintravascular device. Graft 3 located on stapler 1 is fixated thereonvia adjusting screw 76. By driving in this adjusting screw 76 pressureend 74 of control lever 72 and pressure rod 20 are acted upon. As aresult, U-shaped staples 28 slightly extend from die 14, prick by theirpointed ends graft 3 to fix temporarily its position on die 14 ofstapler 1. Stapler 1 is ready for work.

At the next stage there is created by surgical procedure duct 202 toapproach the lumen of an operated blood vessel, substantially aorta 200,directly through the wall of this blood vessel (aorta). Then, throughthus opened duct 202, there is inserted into the lumen of an operatedblood vessel, substantially aorta 200, a special stapler 1 (FIG. 13)with an intravascular device, substantially graft 3 fitted thereover,and this graft 3 is located in a necessary place within aorta 200. Thenstapler 1 is brought into operative position necessary for securing thefirst end of an intravascular device, in this case graft 3, to the wallof a blood vessel, substantially aorta 200. Thereafter there are checkedthe matching of mutual location of the first end 204 of graft 3, theplace of its supposed securing to the wall of aorta 200, as well as ofthe actuator of stapler 1 with fastener means—U-shaped staples 28located in die 14 at its free end.

Then, in the actuator of stapler 1 there is generated an axial forcesufficient for acting on fastener means—U-shaped staples 28. Due to thisforce U-shaped staples 28 extend further from die 14 in radialdirection, punch not only the wall of intravascular device—graft 3, butalso the surrounding wall of aorta 200 in such a way, that the distalends of these U-shaped staples 28 extend in part outside aorta 200 andare bent over on its outer surface to form a rigid connection of firstend 204 of graft 3 with the wall of aorta 200. Next, the actuator ofstapler 1 is moved clear of the first end of aorta 200 wall, so thatU-shaped staples 28 remain fixed in the wall of graft 3 and in the wallof aorta 200 to secure the first end of graft 3 to a correspondingportion of aorta 200 and prevent thereby any its displacement relativeto this aorta 200. Then stapler 1 is brought into inoperative positionnecessary for its free removal and removed from graft 3 and from aorta200.

At the second stage in the intravascular device—graft 3 there is made anincision 206 for access to its lumen (FIG. 13). Then, through previouslycreated duct 202 and incision 206, there is inserted into the lumen ofgraft 3 second special stapler 1 for securing second end 208 of thisgraft 3 to the wall of aorta 200. This stapler 1 is brought intooperative position whereupon its actuator with U-shaped staples 28located in die 14 at its free end is brought to the wall of graft 3, atthe point of securing its second end to the wall of aorta 200. There ischecked the matching of mutual positioning of second end 208 of graft 3,the spot of its supposed securing to the wall of aorta 200, as well asof the actuator of second stapler 1 with U-shaped staples 28. When inthe actuator of this second stapler 1 there is generated an axial forcesufficient to act on U-shaped staples 28, the latter, extending from die14 in radial direction, punch not only the wall of graft 3, but also thesurrounding wall of aorta 200 in such a way that the distal ends ofthese U-shaped staples 28 extend in part outside aorta 200 and are bentover on its outer surface to form a rigid connection of the second end208 of graft 3 with the wall of aorta 200. Then the actuator of secondstapler 1 is moved clear of the wall of graft 3, whereby U-shapedstaples 28 remain fixed in the wall of graft 3 and in the wall of aorta200 to secure the second end 208 of graft 3 to a corresponding portionof aorta 200 and thereby prevent any its displacement relative to thisaorta 200. Next, stapler 1 is brought into inoperative positionnecessary for its free removal from graft 3 and removed therefrom andfrom aorta 200.

At the last step incision 206 in graft 3 and duct 202 for access to thelumen of graft 3 and to the lumen of operated aorta 200 are closed viasurgical procedure. Due to the above manipulations there is created asecure multiple-point connection of graft 3 with the wall of aorta 200which prevents displacement of this graft 3 from an assigned positiondue to blood flow and peristelsic oscillations of the walls of aorta200.

According to the suggested method, it is also possible to secure theends of another intravascular device, such as stent-graft 220 (FIG. 14),having a broad proximal part 222 and bifurcated distal part 224 and 226to the wall of aorta 200. This is accomplished via a set of at least twostaplers 1 and using in each of them simultaneously at least twofastener means—U-shaped staples 28. The set contains at least one firststapler for securing broad proximal part 222 of stent-graft 220 to thewall of aorta 200 and at least one second stapler for securing to thewall of aorta 200 bifurcated distal part 224 and 226 of stent-graft 220.Securing the end of a stent-graft having a broad proximal part 222 tothe wall of aorta 200 in the area of neck 228 of aorta 200 is performedvia the first of staplers 1 comprised in the stapler set and usingsimultaneously at least two U-shaped staples 28.

The distal end of stent-graft 220 having a bifurcated distal part 224and 226 is secured to the wall of aorta 200 via the second of staplerscomprised in the set and using simultaneously at least two U-shapedstaples 28. The securing is performed near the free end of one 224 orother 226 of the branches of bifurcated distal part of this stent-graft220.

At last, according to the claimed method, stent-graft 220 may be securedto the wall of aorta 200 also using at least two U-shaped staples 28near the free end of both branches 224 and 226 of bifurcated distal partof stent-graft 220.

Application of the suggested new and improved method of securing incombination with a new stapling device-laparoscopic stapler 1 operatingon the base of this method allows, in the opinion of the authors, tosolve the problem of providing secure and relatively simple means ofsecuring intravascular devices 3 to blood vessel walls. In particular,their application will allow to solve the problem of securingstent-graft 220 to the wall of aorta 200 or securing to blood vesselwalls grafts 3 or other similar devices if these devices have nosufficient fixation of their own for preventing their displacement fromassigned positions.

While this invention has been described in conjunction with specificembodiment thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, the preferred embodiments of the invention as set forthherein are intended to be illustrative, not limiting. Various changesmay be made without departing from the spirit and scope of the inventionas defined in the following claims.

1. A method for intraluminal fixation of intravascular devices,substantially grafts or stent-grafts, including the following successivesteps: a) preparing a special stapler for operation by checking thestate of its loading with fastener means and following fitting over thebody of this stapler a corresponding intravascular device, substantiallygraft or stent-graft, with partially reversing, if necessary, one end ofthis intravascular device, as well as securing the latter on the staplerbody via a means for its temporary fixation. b) creating by surgicalprocedure a duct for access to the lumen of an operated blood vessel,substantially the aorta, directly through the wall of this blood vessel;c) inserting through said duct into the lumen of an operated bloodvessel, substantially the aorta, a special stapler with a correspondingintravascular device, substantially graft or stent, fitted over andsecured thereon, and locating this intravascular device in necessaryposition; d) bringing the stapler into operative position for securingthe first end of this intravascular device to the wall of the givenblood vessel, substantially the aorta; e) checking of the matching ofmutual location of the first end of this intravascular device, the placeof its supposed securing to the blood vessel wall, as well as of theactuator of said stapler with fastener means located near its free end;f) generating in said stapler actuator radial forces sufficient foracting on these fastener means, whereby these fastener means, extendingfrom the actuator in radial direction, punch the wall of saidintravascular device and surrounding blood vessel wall in such a way,that the distal ends of these fastener means partly extend outside theblood vessel and are bent over on its outer surface to provide a rigidconnection of the first end of said intravascular device with the bloodvessel wall; g) moving said stapler actuator clear of the first end ofthe wall of said intravascular device, whereby said fastener meansremain fixed in the wall of said intravascular device and in the bloodvessel wall, securing the first end of intravascular device to acorresponding portion of the blood vessel and preventing thereby any itsdisplacement relative to this blood vessel; h) bringing the stapler intoinoperative position necessary for its free removal from saidintravascular device and from said blood vessel; i) removing the staplerfrom the blood vessel; l) making an incision in said intravasculardevice for access to its lumen; m) inserting through said duct andthrough said incision into the lumen of said intravascular device,substantially graft or stent-graft, another special stapler for securingthe second end of this intravascular device to the wall of this bloodvessel, substantially the aorta; n) bringing the second special staplerinto operative position for securing the second end of thisintravascular device to the wall of this blood vessel; o) bringing tothe wall of said intravascular device, at the point of securing itssecond end to the blood vessel wall, the actuator of said other stapler;p) checking the matching of mutual location of the second end of thisintravascular device, at the point of its supposed securing with theblood vessel wall, as well as of the actuator of said other stapler withfastener means located near its free end; q) generating in said actuatorof this stapler radial forces sufficient for acting on said fastenermeans, whereby these fastener means, extending from the actuator inradial direction, punch the wall of said intravascular device andsurrounding blood vessel wall in such a way that distal ends of thesefastener means extend in part outside the blood vessel and are bent overon its outer surface to provide a rigid connection of the second end ofthis intravascular device with the blood vessel wall; r) moving saidactuator of the other stapler clear of the wall of said intravasculardevice, whereby said fastener means remain fixed in the wall of saidintravascular device and in the blood vessel wall, securing the secondend of said intravascular device to a corresponding portion of the bloodvessel and preventing thereby any its displacement relative to thisblood vessel; s) bringing the other stapler in inoperative positionnecessary for its free removal from said intravascular device and fromsaid blood vessel; t) removing the stapler from the blood vessel; u)closing by surgical procedure said incision in the intravascular deviceand said duct for access to the lumen of this intravascular device andto the lumen of the operated blood vessel, whereby there are providedsecure multiple-spot connections of the intravascular device with ablood vessel wall which prevent displacement of this intravasculardevice from an assigned position due to blood flow and peristelsicoscillations of blood vessel wall.
 2. A method according to claim 1,wherein the ends of said intravascular device, substantially graft orstent-graft, are secured to a blood vessel wall via at least one saidstapler and using at least two said fastener means, simultaneously morethan at two points, substantially near one of the free ends of thisintravascular device.
 3. A method according to claim 1, wherein the endsof said intravascular device, substantially graft, are secured to ablood vessel wall via a set of at least two said staplers and using ineach of these staplers simultaneously at least two said fastener meanssecured simultaneously more than at two points, substantially near eachof free ends of this intravascular device.
 4. A method according toclaim 1, wherein the ends of said intravascular device, substantiallystent-graft, having a broad proximal part and bifurcated distal part aresecured to the wall of a blood vessel, substantially the aorta, via aset of at lest two said staplers and using in each of themsimultaneously at least two said fastener means.
 5. A method accordingto claim 4, wherein the ends of said intravascular device, substantiallystent-graft having a broad proximal part and bifurcated distal part aresecured to the wall of a blood vessel, substantially the aorta, via aset of at least two said staplers and using in each of themsimultaneously at least two said fastener means, the set containing atleast one first stapler for securing the broad proximal part ofstent-graft to the aorta wall and at least one second stapler forsecuring to said aorta wall the bifurcated distal part of thestent-graft.
 6. A method according to claim 5, wherein the proximal endof said intravascular device, substantially stent-graft, having a broadproximal part and bifurcated distal part is secured to the wall of ablood vessel, substantially the aorta, in the area of this aorta neckvia the first of said staplers comprised in said set and usingsimultaneously at least two said fastener means.
 7. A method accordingto claim 5, wherein the distal end of said intravascular device,substantially stent-graft, having a broad proximal part and bifurcateddistal part is secured to the wall of a blood vessel, substantiallyaorta, via the second of said staplers and using simultaneously at leasttwo said fastener means, near the free end of one of the branches of thedistal part of this stent-graft.
 8. A method according to claim 5,wherein the distal end of said intravascular device, substantiallystent-graft having a broad proximal part and bifurcated distal part issecured to the wall of a blood vessel, substantially the aorta, via thesecond of said staplers and using simultaneously at least two saidfastener means, near the free end of the other of the branches ofbifurcated distal part of this stent-graft.
 9. A method according toclaim 5, wherein the distal end of said intravascular device,substantially stent-graft, having a broad proximal part and bifurcateddistal part is secured to the wall of a blood vessel, substantially theaorta, via the second of said staplers and using simultaneously at leasttwo said fastener means, near the free ends of both branches of thebifurcated distal part of this stent-graft.
 10. A stapler forlaparoscopic aortic repair by intraluminal fixation of intravasculardevices, substantially grafts or stent-grafts, comprising: i) a tubularbody configured for positioning within a blood vessel, this tubular bodybeing rigid in longitudinal direction and flexible in lateral direction;ii) a substantially cylindrical head disposed at the free end of thistubular body and having an inner axial cavity, a proximal end and adistal end, a die and die lid being rigidly mounted at the proximal endof this head, said die and die lid being coaxial with this head and withone another; iii) A die for receiving fastener means, substantiallyU-shaped staples, shaped substantially as a barrel having a proximalend, a distal end, a substantially cylindrical generatrix and an inneraxial cavity open on the side of said barrel distal end and terminatingin a bottom at said proximal end of the barrel, this bottom having athrough axial hole, through, evenly arranged radial slots, and on itsend face presented to the die lid—recesses with grooves for receivingfastener means, substantially U-shaped staples, these recesses withgrooves being coaxial with said radial slots and provided with means forsetting apart the ends of said U-shaped staples, this means are disposedalong the axes of grooves, immediately adjacent to the cylindricalgeneratrix of said die and are substantially V-shaped; iv) a die lidhaving a through axial hole, a substantially cylindrical generatrix, aproximal an distal end faces, radial slots evenly arranged in the bodyof the die of said lid near its distal end face and extending onto itscylindrical generatrix, as well as means for retaining the free ends ofU-shaped staples and means for separating from the stapler the middlesof these U-shaped staples at the end of their working stroke, thesemeans being disposed near the points of intersection of said radialslots with said distal end face and said cylindrical generatrix of saiddie lid; v) a control mechanism disposed at the end of said tubular bodyopposite to said head and including a substantially cylindrical hollowbody with a proximal end and a distal end, with a retaining handleextending from this distal end sidewise at a certain angle, from about30 degrees to about 90 degrees, and a control lever pivotally mounted onsaid retaining handle; vi) a pressure rod located within said hollowbody, having a longitudinal axis, a proximal end and a distal end, thispressure rod being rigid in longitudinal direction and flexible inlateral direction and operatively associated via its distal end withsaid control lever, and its proximal end being substantially conical andreciprocably located in the inner axial cavity of said die; vii) meansfor transmitting axial force from said pressure rod to said fastenermeans, substantially U-shaped staples, and for transforming this axialforce into radial forces applied to each of these U-shaped staples,located substantially in said inner axial cavity of the die toperiodically cooperate with the proximal end of said pressure rod; viii)a means for temporary fixation on the stapler body of deliveredintravascular devices, substantially grafts or stent-grafts, located onthis body stapler outside, whereby said intravascular device isdelivered into a required area of the blood vessel and secured on thewall within this blood vessel, the free ends of fastener means,substantially U-shaped staples, punch the wall of said intravasculardevice and the surrounding blood vessel wall and extend in part outsidea corresponding blood vessel to form a rigid connection of saidintravascular device with the blood vessel wall.
 11. A stapler accordingto claim 10, wherein said substantially cylindrical hollow body of thecontrol mechanism has a proximal end and a distal end with retaininghandle extending from this distal end sidewise at a certain angle, fromabout 30 degrees to about 90 degrees, this retaining handle beingprovided with a swing lock and control lever pivotally mounted on saidretaining handle, said control lever having a pressure end movablymounted within the hollow body in the clearance between thespring-loaded end of said pressure rod and adjusting screw coaxial withthis pressure rod.
 12. A stapler according to claim 10, wherein said diefor receiving fastener means is shaped as a barrel with a substantiallycylindrical generatrix and inner axial cavity open on the side of thedistal end of this barrel and terminating in a bottom at the proximalend of said barrel, the die has through, evenly disposed radial slots onits bottom, and on the end face of this bottom presented to said diebottom - recesses with grooves for receiving fastener means,substantially U-shaped staples, and with means for setting apart theends of the latter, these recesses with grooves have substantially thesame depth relative to said end face of the die bottom and are coaxialwith the radial slots.
 13. A stapler according to claim 10, wherein saiddie for receiving fastener means, substantially U-shaped staples, isshaped as a barrel with a substantially cylindrical generatrix and inneraxial cavity open on the side of the distal end of this barrel andterminating in a bottom at the proximal end of said barrel, the die hasthrough, evenly disposed radial slots on its bottom, and on the end faceof this bottom presented to said die lid-recesses with grooves forreceiving fastener means and with means for setting apart the ends ofthe latter, these recesses with grooves have substantially differentdepths relative to said end face of said die bottom and are coaxial withthe radial slots.
 14. A stapler according to claim 13, wherein saidrecesses with grooves have at least two different depths relative tosaid end face of the die bottom, recesses with grooves of differentdepths alternating with one another.
 15. A stapler according to claim10, wherein said fastener means are formed substantially as U-shapedstaples and located radially in said grooves of said stapler die toextend radially from these grooves due to radial forces, the free endsof said U-shaped means being disposed on both sides of said means forsetting apart the ends of these fastener means located along the axes ofsaid grooves, immediately adjacent to the cylindrical generatrix of saiddie and being substantially V-shaped;
 16. A stapler according to claim15, wherein said means for setting apart the ends of said fastenermeans, substantially U-shaped staples, are disposed along the axes ofgrooves, immediately adjacent to the cylindrical generatrix of said dieand are substantially V-shaped, with lateral guiding faces which aresubstantially curvilinear, concave and diverging from one another indirection from the center of said die towards its cylindricalgeneratrix, which allows to bend outward the free ends of fastener meansduring their extension from the die due to said radial forces.
 17. Astapler according to claim 15, wherein said means for setting apart theends of said fastener means, substantially U-shaped staples, aredisposed along the axes of grooves, immediately adjacent to thecylindrical generatrix of said die and are substantially V-shaped, withlateral faces, which are substantially radial, concave and diverge fromone another in direction from the center of said die towards itscylindrical generatrix, which allows to bend outward the free ends offastener means during their extension from the die due to said radialforces.
 18. A stapler according to claim 10, wherein said die lid isprovided with means for retaining the free ends of said fastener means,substantially U-shaped staples, which contain torsion spring elementsdisposed near the points of intersection of said radial slots with saiddistal end face and said cylindrical generatrix of this die lid.
 19. Astapler according to claim 10, wherein said die lid is provided withmeans for separating from this stapler the middles of said fastenermeans, substantially U-shaped staples, at the end of their workingstroke, these means containing recesses located near the points ofintersection of said radial slots with said distal end face and saidcylindrical generatrix of this die lid.
 20. A stapler according to claim10, wherein said die lid is made of a transparent material for checkingthe state of fastener means, substantially U-shaped staples.
 21. Astapler according to claim 10, wherein said pressure rod has alongitudinal axis, substantially conical proximal end, distal end andthrust collar near its distal end, this pressure rod is rigid inlongitudinal direction and flexible in lateral direction, the pressurerod being spring-loaded, operatively associated by its distal end withsaid control lever and capable of reciprocation by its distal end—withinsaid hollow body of the control mechanism, and by its substantiallyconical proximal end—within said inner axial cavity of the die.
 22. Astapler according to claim 21, wherein said pressure rod has asubstantially conical proximal end with a cone vertex angle from about 3to about 35 degrees.
 23. A stapler according to claim 22, wherein saidpressure rod has a substantially conical proximal end with a cone vertexangle from about 10 degrees to about 20 degrees.
 24. A stapler accordingto claim 10, wherein said means for transmitting axial force from saidpressure rod to said fastener means, substantially U-shaped staples, andfor transforming this axial force into radial forces applied to each ofthese U-shaped staples contain curved L-shaped levers pivotally mountedby the ends of their long arms near the free end of said hollow body andevenly arranged within said inner axial cavity of the die in such a way,that their short arms bent outward relative to the longitudinal axis ofthe die, are disposed in corresponding through radial slots on thebottom of this die, said curved L-shaped levers being configured toperiodically cooperate by inner faces of their long arms with saidsubstantially conical proximal end of the pressure rod, and by theirfree ends of short arms bent outward—with the middles of correspondingU-shaped staples.
 25. A stapler according to claim 24, wherein saidcurved L-shaped levers are pivotally mounted by the ends of their longarms on a ring located within said inner axial cavity of the die, in aclearance between the free end of said head and inner ribs of this dieextending from the wall of its inner axial cavity in direction to thedie longitudinal axis, said ribs having evenly arranged radial slots,and in each of the latter there is movably located a correspondingcurved L-shaped lever.
 26. A stapler according to claim 10, wherein saiddie, die lid and fastener means, substantially U-shaped staples locatedin the die grooves form in combination a single set of the stapleractuator which is configured to be removed from said stapler body andthen replaced by other, similar interchangeable sets.
 27. A stapleraccording to claim 10, wherein said means for temporary fixation on thestapler body of delivered intravascular devices, substantially grafts orstent-grafts, located on this stapler body outside containssubstantially an adjusting screw with a thrust head located in thedistal part of said body of the control mechanism, coaxially with saidpressure rod and on the other side of the pressure end of said controllever, as well as fastener means, substantially U-shaped staples,wherewith said adjusting screw is operatively associated via thepressure end of said control lever and said pressure rod.